DECISION TREE IMPLEMENTATION WITH FIRST INTENT PACKAGING CONCEPT FOR GENERIC SOLID ORAL DOSAGE FORMS DRUG PRIMARY PACKAGING SELECTION

• Main Author: Putri Yudianti Yudison, Dwi
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/37237
• Institution: Institut Teknologi Bandung

Selection of primary packaging material is an important step in drug packaging development to ensure the quality of drug products can be maintained during the shelf life. To make the right choice of primary packaging material for the drug, it is necessary to review the suitability of its packaging material. This suitability is assessed based on protection capability of the packaging material, compatibility between the packaging material and the drug product, safety of the packaging material to be used and in contact with the drug product, and performance of the packaging material. Consideration of the suitability of primary packaging material must also be applied to the development of generic solid oral dosage form drug. The easiest way to select primary packaging materials for generic drugs is to follow the packaging that is used by the originator drug product. However, in some cases, the selection of primary packaging material in accordance with that used by the originator's drug cannot produce good / equivalent product quality. So that we need other primary packaging material alternatives that can ensure the quality of products that are equal or better. Primary packaging materials for solid oral dosage forms drug have a variety of types and compositions, as well as their protective ability. Although there are many types, compositions, as well as primary packaging material protection capabilities of solid oral dosage forms drug, there were only 14 compositions which is used in the DDD industry to package solid oral dosage forms drug. For the selection of primary packaging material use among the 14 compositions, a tool is needed, so that the selection of packaging material for solid oral dosage forms drug in the DDD Industry is based on proper justification. This study aims to develop a tool for the selection of primary packaging materials for generic solid oral dosage forms drug which are presented in the form of a decision tree by considering the application of the concept of first intent packaging in the DDD industry. Application of the first intent packaging concept in the DDD industry is based on the availability of material types and packaging material protection characteristics. In this research, packaging protection testing against water vapor (water vapor transmission rate, WVTR) was carried out for polycellonium strip pack (with 12 micron aluminium), Aluminium - PVC250/PVDC60 blister pack, and Aluminium - PVC250/PE25/PVDC90 blister pack to find out the material protection characteristics compared to other types of material. Choice hierarchy of primary packaging materials for generic drug products in the DDD industry based on packaging protection against water vapor (water vapor transmission rate, WVTR) are: Alu - Alu blister (with OPA25/AL45/PVC60 forming material composition) << Polycellonium strip pack (with 12-18 micron Aluminium) << Aluminium - PVC250/PE25/PVDC90 blister pack<< Aluminium - PVC250/PVDC60 blister pack << Aluminium - PVC blister pack. Based on the packaging material selection range that has been prepared, a decision tree is made by assessment of the drug product characteristic and protection capability of each type primary packaging material.